The effect of the BNT162b2 vaccine on antinuclear antibody and antiphospholipid antibody levels

Abstract

The Food and Drug Administration (FDA) approved the first SARS-CoV-2 mRNA vaccine (Pfizer-BioNTech) in December 2020. New adverse events have emerged since these vaccines have reached market. Although no clear association between messenger ribonucleic acid (mRNA) vaccines and autoimmunity has emerged, the significance of such an association warrants further exploration. After obtaining consent, a standardized survey on baseline characteristics and other relevant variables was conducted on unvaccinated individuals who were scheduled for vaccination and had not previously contracted COVID-19. Blood samples were collected from participants prior to the first dose, prior to the second dose, and 1 month after the second dose. All collected samples were tested for antinuclear antibody (ANA) titers using indirect immunofluorescence microscopy kits, and antiphospholipid (APS) immunoglobulin M (IgM) and immunoglobulin G (IgG) levels using an enzyme-linked immunoassay (ELISA) technique. ANA titers were positive for 9 participants out of 101 (8.9%) in the first pre-vaccination draw. For the second draw, the number of participants testing positive for ANA decreased to 5 (5%). For the last draw, 6 (5.9%) participants tested positive for ANA titers. One participant tested positive for APS IgM at the first pre-vaccination draw, 2 tested positive at the second draw, and 2 at the third draw. As for APS IgG titers, all participants tested negative in the three draws. McNemar’s test for two dependent categorical outcomes was conducted on all variables and did not show a statistical significance. The McNemar test of these two composite variables (i.e., ANA/APS, first draw vs. ANA/APS, second and third draws) did not show statistical significance. The 2-sided exact significance of the McNemar test was 1.0. The Friedman test also showed no significance ( p = 0.459). No association was found between BNT162b2 vaccine administration and changes in APS and ANA titers. The benefits of the BNT162b2 vaccine significantly outweigh any possible risk of autoimmune dysregulation considering the current evidence.

Venous thromboembolism after COVID‐19 vaccination in patients with thrombophilia

“…19 In patients without APS, there has also been no evidence that COVID-19 vaccinations are inducing production of antiphospholipid antibodies. 20 Our data from 1021 patients with APS provides a robust assessment of VTE risk in a larger sample and is consistent with these smaller studies indicating no elevated VTE risk for COVID-19 vaccination in APS patients.…”

COVID-19, post-acute COVID-19 syndrome (PACS, “long COVID”) and post-COVID-19 vaccination syndrome (PCVS, “post-COVIDvac-syndrome”): Similarities and differences

“…Autoantibodies were detected during the acute phase of COVID-19 [316] , [317] , [318] , [319] , [320] , [321] , [322] , [323] , [324] , [325] , [326] , [327] , [328] , [329] , [330] , [331] , [332] , [333] , months afterwards (predicting PACS symptoms) [334] , [335] , in PACS [336] , [337] , [338] , [339] , [340] , and in PCVS [295] , [298] , [341] , [342] , [343] , [344] , [345] , [346] , [347] , [348] , [349] , [350] , [351] , [352] , [353] , [354] , [355] , [356] , [357] , [358] , [359] , [360] , [361] , [362] , [363] , [364] , [365] . In the absence of PCVS after COVID-19 vaccination, autoantibodies are generally not present [366] , [367] , [368] . However, in some documented cases, individuals have shown a significant increase in antiphospholipid IgM autoantibody levels, for example, after each COVID-19 vaccine dose (with accompanying transient fatigue and malaise) [368] .…”

“…In the absence of PCVS after COVID-19 vaccination, autoantibodies are generally not present [366] , [367] , [368] . However, in some documented cases, individuals have shown a significant increase in antiphospholipid IgM autoantibody levels, for example, after each COVID-19 vaccine dose (with accompanying transient fatigue and malaise) [368] .…”

Longitudinal Analysis of Antiphospholipid Antibody Dynamics after Infection with SARS-CoV-2 or Vaccination with BNT162b2

“…Several authors have studied the induction of autoantibodies after BNT162b2 vaccination, and in most cases no significant induction of autoantibodies was observed. Borghi et al published that vaccination with BNT162b2 and also ChAdOx1 did not induce early autoantibody production [37], Noureldine et al found no clear pattern of an increase in aPL titers, with the exception of one female participant who had a significant increase in aPL IgM levels after each dose [38], and Thurm et al concluded that vaccines do not significantly promote the occurrence of autoantibodies, which are commonly associated with various systemic autoimmune diseases [39]. Importantly, the few isolated cases in which autoantibodies developed after vaccination are not sufficient to establish a link between vaccination with BNT162b2 mRNA vaccine and autoimmune markers.…”